Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

This study is looking at how well a device called the Sana Pain Reliever (Sana PR) can help reduce chronic pain in people with Post-treatment Lyme Disease Syndrome (PTLDS). The Sana PR is a mask with earbuds that you wear over your eyes. It uses light pulses and sounds, and also measures your heart rate variability (HRV). You might be able to join if you are 18 or older, have a confirmed diagnosis of neuropathic pain (nerve pain), and have PTLDS based on specific Columbia Clinical Trial Network criteria. The study will measure your pain levels using a survey called the Neuropathic Pain Symptom Inventory at different times over 14 weeks to see if the Sana PR is effective. The study is currently unclear about its recruitment status and plans to include 20 participants.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It will involve 20 participants.
What's involved: You would wear the Sana PR device for 15 minutes at a time and answer questionnaires. The total study duration is 14 weeks.
Compensation: Not stated in the trial record.
Follow-up: Your pain levels will be measured at baseline, after 10 weeks, and then again at 14 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

Recruiting

NAAges 18+InterventionalTreatment

Icahn School of Medicine at Mount Sinai

~20 participants

Updated 2026-05-18 on ClinicalTrials.gov

What's tested:Sana Pain RelieverSham SPR

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Neuropathic Pain Symptom Inventory

Measured over Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

Conditions

Post-treatment Lyme Disease Syndrome

Chronic Pain

Where it's being run

1 sites across 1 states

New York1

Study leadership

David Putrino, PT, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Laura Tabacof, MD

[email protected]

212-241-8454

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Confirmed clinical diagnosis of neuropathic pain AND

Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome

Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:

Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition

Erythema Migrans

History of possible exposure to a high incidence county or state (or an adjacent area)

Erythema migrans rash

EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)

EM 1A: MOA self-report \& medical record documentation of rash \> 5 cm

EM 1B: MOA: self-report and medical record documentation of EM rash but not size

EM 1C: MOA: self-report \& rash misdiagnosed in medical record as cellulitis/spider bite

EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR Disseminated "objective" manifestation with lab test confirmation of Bb infection

Clinical history includes at least one of the following symptoms/signs, which are not better accounted for by another cause (MOA: medical records and/or self-report).

Neurologic: Lymphocytic Meningitis; Encephalitis; Encephalomyelitis, Cranial Neuritis (especially facial palsy); Radiculoneuropathy;

Other Neurologic Signs (with objective measures): Encephalopathy, Polyneuropathy

Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis

Lyme arthritis: Recurrent joint swelling in one or more joints

Dermatologic: Disseminated EM ("satellite") or Acrodermatitis atrophicans AND

Lab test Confirmation (previous) (requires at least one of the Class 1 lab tests) (MOA: self-report \& documentation) Group 2. Probable.

Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation

Class 1 lab test confirmation (excluding IgM WB)

Highly suggestive IgG WB (4 of 10 bands) OR EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR

Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard twotiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report)

Ages 18+

Fluent in English

Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)

Exclusion

Diagnosis of photosensitive epilepsy

Ear or eye infection

Vision impairments that affect perception of light in one or both eyes

Deafness in one or both ears

Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if participants self- report having anxiety)

What this trial measures

Neuropathic Pain Symptom InventoryBaseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-10 with higher score indicating more symptom. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

Trialytics